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Biotin Side Effects

The most commonly reported side effects of biotin include fatigue, nausea, and alopecia, based on 35,441 FDA adverse event reports from 2004 to 2025. 5.6% of reports found the drug to be ineffective.

Biotin side effects

Percentages show how often each reaction appears relative to total reports for biotin.

1
Fatigue8.8%3,132
2
Nausea6.5%2,303
3
Alopecia6.2%2,214
4
Headache6.2%2,193
5
Drug Ineffective5.6%1,996
6
Diarrhoea5.5%1,946
7
Pain4.9%1,727
8
Dizziness4.6%1,616
9
Off Label Use4.2%1,503
10
Dyspnoea4.1%1,449
11
Arthralgia4.1%1,448
12
Pruritus3.6%1,292
13
Fall3.4%1,194
14
Asthenia3.1%1,091
15
Pain In Extremity3.1%1,084

These are voluntary reports and do not establish that biotin caused these reactions.

Report severity

47.9%Serious16,978 reports
20.1%Hospitalizations7,133 reports
3.3%Fatal1,168 reports

Seriousness is determined by the reporter, not by OpenClaim.

Biotin drug interactions

Other drugs that appear in adverse event reports alongside biotin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Adalimumab5.0%1,761
2
Sodium-oxybate4.6%1,646
3
Lenalidomide4.3%1,511
4
Minoxidil3.6%1,261
5
Dupilumab2.7%944
6
Niacin2.6%935
7
Dalfampridine2.4%868
8
Dimethyl1.8%643
9
Etanercept1.7%620
10
Tofacitinib1.7%598
11
Treprostinil1.5%526
12
Palbociclib1.4%486
13
Apremilast1.3%464
14
Fingolimod1.3%457
15
Teriflunomide1.2%443

Taken alongside

1
Ergocalciferol52.6%18,659
2
Cyanocobalamin28.7%10,180
3
Ascorbic-acid26.6%9,438
4
Aspirin22.9%8,105
5
Folic-acid21.2%7,505
6
Calcium20.9%7,407
7
Acetaminophen19.9%7,064
8
Levothyroxine-sodium19.0%6,740
9
Vitamin-e17.0%6,025
10
Fish14.2%5,016
11
Omeprazole13.8%4,907
12
Pyridoxine12.8%4,533
13
Vitamin-a12.8%4,528
14
Thiamine12.7%4,507
15
Riboflavin12.7%4,493

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports biotin side effects

81.6% of biotin adverse event reports involve female patients and 13.8% involve male patients. The largest age group is adult at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female81.6%
Male13.8%
Unknown4.6%

Age group

< 20.6%
2–110.4%
12–170.6%
18–6455.2%
65+43.3%

What is biotin used for

Conditions and purposes for which patients were taking biotin when the adverse event was reported.

AcidosisAdjuvant TherapyAdverse EventAlopeciaAlopecia AreataAlopecia UniversalisAmnesiaAnaemiaAndrogenetic AlopeciaAntibiotic TherapyAntimitochondrial Antibody PositiveAntiviral ProphylaxisAnxietyAppetite DisorderArthritis

Showing 15 of 358 indications

Biotin brand names and reporting trend

Biotin is sold under the brand name M.v.i.-12 Adult.

Brand names

M.v.i.-12 Adult32,619

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking biotin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.